MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/60MM; SCREW, FIXATION, BONE

Model Number	02.231.260
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in great britain as follows: patient sustained periprosthetic fracture (ppf) below femoral nail in march and was fixed with va condylar plate on an unknown date in march 2022.Patient was readmitted approximately 3 months after implant with plate fracture.No new trauma.Had been mobilizing in residential home.Normal to low bmi.Fracture non-united, but no evidence of infection.Revision occurred (b)(6) 2022.This is report 7 of 11 for (b)(4).This report is for a locking screw.This complaint is linked to (b)(4).
Additional Manufacturer Narrative
Additional narrative: date of event: unknown between (b)(6) 2022 and (b)(6) 2022.Implant date: unknown date in (b)(6) 2022.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter name: initial reporter is j&j company representative.Investigation summary: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo revealed that the va lockscr ã¸5 self-tap l60 sst had no signs of issue or defect.X-ray evidence provided shows a plate and screw construct at the left distal femur with signs of bone and plate breakage.No other issues were identified.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 not confirmed for the va lockscr ã¸5 self-tap l60 sst.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 history: part number: 02.231.260s, lot number: 433p007, manufacturing site: (b)(4), release to warehouse date: 26 oct 2021, expiration date: 1 oct 2031.A manufacturing record evaluation was performed for the sterile lot number and no non-conformances were 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: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/60MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15077703
• Report Number: 8030965-2022-05063
• Device Sequence Number: 5489332
• Product Code: HWC
• UDI-Device Identifier: 10886982062192
• UDI-Public: (01)10886982062192
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02.231.260
• Device Catalogue Number: 02.231.260S
• Device Lot Number: 433P007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CERCL-CABLE W/CRIMP Ø1.7 SST; CERCL-CABLE W/CRIMP Ø1.7 SST; LOCKING ATTACHMENT PLATE 3.5 F/LCP 4.5/5; VA LOCKSCR Ø5 SELF-TAP L36 SST; VA LOCKSCR Ø5 SELF-TAP L38 SST; VA LOCKSCR Ø5 SELF-TAP L60 SST; VA LOCKSCR Ø5 SELF-TAP L65 SST; VA LOCKSCR Ø5 SELF-TAP L75 SST; VA PERIPROSTHETIC LOCK SCREW Ø5 SELF-TAP; VA-LCP CONDYLAR PLATE 4.5/5.0 LE 12HO L2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female