MAUDE Adverse Event Report: SYNTHES GMBH DISTRACTOR FOR 11MM ROD; APPARATUS, TRACTION, NON-POWERED

Model Number SD393.640

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that on an unknown date after a case one of the bolts was off its threads and upon trying to loosen the bolt it stripped the threads.No additional information was reported.This report is for one (1) distractor for 11mm rod.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter occupation is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h4: manufacture date added.H3, h4, h6: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot part number: sd393.640-us lot number: 20p0890 supplier lot number: 162353 manufacture date or release to warehouse date: 07/14/2020 expiration date: n/a supplier/manufacture site: avalign / brandywine an ncr was generated for production lot number 20p0890, for dimensional issue (thread minor diameter oversize).The 1 affected assembly was function tested by product development and dispositioned the parts as use-as-is, therefore the non-conformance is not relevant to the complaint issue as the part functioned correctly and the minor out of spec condition would not impact the assembly.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Component part number: 393.502 lot number: 19p8444 supplier lot number: n/a manufacture date or release to warehouse date: 10/09/2019 expiration date: n/a supplier/manufacture site: brandywine no ncrs were generated during component production of lot number 19p8444.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Component part number: 393.500 lot number: 14l8063 supplier lot number: n/a manufacture date or release to warehouse date: 08/19/2019 expiration date: n/a supplier/manufacture site: brandywine no ncrs were generated during component production of lot number 14l8063.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Component part number: 393.45a component lot number: 19p8446 supplier lot number: n/a manufacture date or release to warehouse date: 10/08/2019.Expiration date: n/a supplier/manufacture site: brandywine no ncrs were generated during component production of lot number 19p8446.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Component part number: 393.45a component lot number: h849566 supplier lot number: n/a manufacture date or release to warehouse date: 03/15/2019.Expiration date: n/a supplier/manufacture site: brandywine no ncrs were generated during component production of lot number h849566.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Component part number: 393.45b component lot number: 17p4476 supplier lot number: n/a manufacture date or release to warehouse date: 09/26/2019.Expiration date: n/a supplier/manufacture site: brandywine no ncrs were generated during component production of lot number 17p4476.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Component part number: 393.45c component lot number: 16l2322 supplier lot number: n/a manufacture date or release to warehouse date: 09/04/2019.Expiration date: n/a supplier/manufacture site: brandywine no ncrs were generated during component production of lot number 16l2322.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Component part number: 393.501 component lot number: 17p8214 supplier lot number: n/a manufacture date or release to warehouse date: 09/18/2019 expiration date: n/a supplier/manufacture site: brandywine no ncrs were generated during component production of lot number 17p8214.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sub-component part number: 393.501a component lot number: 15l6675 supplier lot number: n/a manufacture date or release to warehouse date: 08/29/2019 expiration date: n/a supplier/manufacture site: brandywine no ncrs were generated during component production of lot number 15l6675.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sub-component part number: 393.501b component lot number: 17p0806 supplier lot number: n/a manufacture date or release to warehouse date: 09/14/2019 expiration date: n/a supplier/manufacture site: brandywine no ncrs were generated during component production of lot number 17p0806.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Component part number: 393.501 component lot number: 14l0264 supplier lot number: n/a manufacture date or release to warehouse date: 07/30/2019 expiration date: n/a supplier/manufacture site: brandywine no ncrs were generated during component production of lot number 14l0264.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sub-component part number: 393.501a component lot number: 3l39425 supplier lot number: n/a manufacture date or release to warehouse date: 06/04/2019 expiration date: n/a supplier/manufacture site: brandywine no ncrs were generated during component production of lot number 3l39425.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sub-component part number: 393.501b component lot number: 10l1561 supplier lot number: n/a manufacture date or release to warehouse date: 06/19/2019 expiration date: n/a supplier/manufacture site: brandywine no ncrs were generated during component production of lot number 10l1561.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device history review a manufacturing record evaluation (device history record(s)) was performed for the non-sterile finished device 20p0890 number, and no non-conformances / manufacturing irregularities related to the malfunction were identified that would contribute to the complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DISTRACTOR FOR 11MM ROD
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16042459
• MDR Text Key: 308354095
• Report Number: 8030965-2022-11481
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD393.640
• Device Catalogue Number: SD393.640
• Device Lot Number: 20P0890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1