MAUDE Adverse Event Report: SYNTHES GMBH 7.3MM CANNULATED SCREW FULLY THREADED/150MM-STERILE; SCREW,FIXATION,BONE

Catalog Number 209.750S

Device Problems Nonstandard Device (1420); Device-Device Incompatibility (2919)

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

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during an unknown procedure, the 7.3mm cannulated screw was found to not be cannulated and unable to be used over a k-wire.There was a surgical delay of ten (10) minutes.The procedure was successfully completed using another screw.There was no patient consequence.This report is for one (1) 7.3mm cannulated screw fully threaded/150mm-sterile.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, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H6: a product investigation was conducted.Visual inspection: the cannscr ø7.3 self-drill l150 sst (p/n: 209.750s & lot #: 90p4296) was returned to jabil grenchen in an opened non depuysynthes bag.Upon visual inspection, the complaint condition is rated as confirmed and valid as the spiral chip was found in the cannulation.The origin of the spiral chip can be confirmed from the manufacturing site and it got undetected during the process steps.No other issues were identified with the device.Functional test: the device failed the functionality test performed at jabil grenchen site as the k-wire was not able to pass through the cannulated screw due to the presence of spiral chip inside the cannulation.Thus the presence of the spiral chip generated during manufacturing caused the complaint condition of "unable to assemble" for the cannulated screw.Document/specification review: the relevant documents were reviewed by jabil grenchen.No discrepancies or deviations were reported.Dimensional inspection: no dimensional inspection was performed as there was no damage that warranted dimensional inspection.Conclusion: the overall complaint was confirmed for the cannulated screw.There was a manufacturing defect or deficiency identified because there was a spiral chip in the cannulation from the screw.The jabil nc was opened to further evaluate this manufacturing defect.Based on the evaluation performed through jabil nc, the jbl-capa was opened to perform the corrective action on the manufacturing error that caused the spiral chip.The jnj nr opened in our system records all the deviations, non conformities and corrective action taken through jbl-nr at jabil grenchen site.H6: a device history record (dhr) review was conducted: product code: 209.750s.Lot number: 90p4296.Manufacturing site: grenchen.Release to warehouse date: 10 february 2021.Expiry date: 01.February 2031.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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: 7.3MM CANNULATED SCREW FULLY THREADED/150MM-STERILE
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen CO 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12325126
• MDR Text Key: 266675554
• Report Number: 8030965-2021-06696
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819522220
• UDI-Public: (01)07611819522220
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K161616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209.750S
• Device Lot Number: 90P4296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDE/COMPRESSION/K-WIRES