MAUDE Adverse Event Report: SYNTHES GMBH 7.3MM CANNULATED CONICAL SCREW PARTIALLY THREADED/110MM; PIN, FIXATION, SMOOTH

Catalog Number 02.207.510

Device Problem Device-Device Incompatibility (2919)

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

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: hwc, jdw, and hrs.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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) 2022, at the time of placement of the 7.3 proximal screws, the 110 lengths of both the conical cannulated and the locked cannulated do not pass through the 2.5mm drill guide.The issue is from the rack of screws for these screws remains very narrow, and were tight inside the holes at the bottom, and this caused the thread tips to close up preventing the entry of the guides.This report involves (1) 7.3mm cannulated conical screw partially threaded/110mm.This is report 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

Event Description

This is report 2 of 4 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a manufacturing record evaluation cannot be performed due to lot number being unknown.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 sample revealed that the cannscr ø7.3 short thread l110 sst was found to be deformed from the distal tip.Assembling issues are most likely due to this condition.A dimensional inspection for the cannscr ø7.3 short thread l110 sst and was unable to be performed due to post manufacturing damage.A functional test was unable to be performed since mating device was not returned.The complaint condition was able to be replicated.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 cannscr ø7.3 short thread l110 sst would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed -7.3mm conical screw (current) 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.B5.

• Brand Name: 7.3MM CANNULATED CONICAL SCREW PARTIALLY THREADED/110MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 13977010
• MDR Text Key: 288868033
• Report Number: 8030965-2022-02106
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07611819906259
• UDI-Public: (01)07611819906259
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K000066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.207.510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/27/2022; 06/01/2022
• Supplement Dates FDA Received: 05/25/2022; 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CANN-LOCKSCR Ø7.3 L110 SST.; UNK - GUIDES/SLEEVES/AIMING: GUIDE.; UNK - PLATES: TRAUMA.