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

Catalog Number SD393.640

Device Problem Break (1069)

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

Event Date 11/15/2023

Event Type  malfunction  

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: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h4, h6: according to the information received, it was reported that on nov 15, 2023, during surgery a product was broken by the surgeon.Sales rep took broken product off the field and gave the surgeon a working product, there was 2 minutes surgical delay.Procedure was completed successfully.The product was not returned to depuy synthes, however photo was provided for review.The photo investigation revealed that sd393.640, distractor for 11mm rod was broken near threaded part at the clamp and nut assembly.No further evidence can be observed from the photo to determine the root cause.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the sd393.640, distractor for 11mm rod would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.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.

Event Description

It was reported that on (b)(6) 2023, a product was broken during an open reduction/internal fixation surgery.The broken product was removed, and the surgeon used a working product to complete the procedure successfully.There was a two-minute delay.There were no patient consequences.This report involves one distractor for 11mm rod.This is report 1 of 1 for (b)(4).

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.H3,h4, h6 the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned device found that the distractor for 11mm rod was broken from the connection between the nut and the body assembly, the broken fragment was stuck inside the nut.No other issues were observed.A dimensional inspection for the distractor for 11mm rod was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the distractor for 11mm rod would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Drawing/specifications reviewed sd393_640 rev.E current and manufactured.Dimensional inspection: n/a.H4,h6 12/15/2023 by: (b)(6).Part number: sd393.640-us, lot number: 1151p81, part manufacture date: 12/02/2022, manufacturing location: brandywine, part expiration date: n/a, nonconformance noted: n/a.A review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows the distractor for 11mm rod product was processed through operations of the released routing and had met all specification criteria at the time of release with no issues documented 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: 18275710
• MDR Text Key: 329845945
• Report Number: 8030965-2023-15413
• 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: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD393.640
• Device Lot Number: 1151P81
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2022
• 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
• Patient Sex: Female