MAUDE Adverse Event Report: SYNTHES GMBH 7.3MM CANNULATED LOCKING SCREW 90MM; SCREW, FIXATION, BONE

Model Number 02.207.090

Device Problems Device Slipped (1584); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 12/29/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in canada as follows: it was reported that on (b)(6) 2022, a 7.3 cannulated locking screw that had been used in the second hole of the proximal end of a proximal femur lcp plate became loose and has backed out.This was noticed by the patient several days after surgery when they noticed something popping and clunking.The patient required hardware removal or revision surgery.No further information is available.This report involves one 7.3mm cannulated locking screw 90mm.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: additional device product codes: hrs, hty, jdw.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j employee.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.

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: h6: a manufacturing record evaluation cannot be performed since the lot number is unknown.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the received image(s).Visual analysis of the photo revealed that the 7.3mm cannulated locking screw 90mm had moved from its original positioning.X-ray image provided shows a plate and screw construct at the left proximal femur.Migration of the second most proximal screw can be confirmed since it almost protrudes from the skin and the head is no longer seated at the insertion hole of the plate, the screw has backed out more than halfway through.Functionality of the device cannot be assessed through photo investigation, therefore this condition cannot be confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the 7.3mm cannulated locking screw 90mm.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.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 LOCKING SCREW 90MM
• Type of Device: SCREW, FIXATION, BONE
• 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: 16247764
• MDR Text Key: 308185857
• Report Number: 8030965-2023-01003
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982051875
• UDI-Public: 10886982051875
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K000066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.207.090
• Device Catalogue Number: 02.207.090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: LCP PROXIMAL FEMUR
• Patient Outcome(s): Required Intervention
• Patient Sex: Female