MAUDE Adverse Event Report: GRENCHEN SYNTHES PRODUKTIONS GMBH 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 20; PLATE, FIXATION, BONE

Model Number	201.770
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.Device evaluated by mfr: 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 or Problem Description
It was reported that on (b)(6) 2021, the surgeon was performing a pre-planned bone grafting of a distal tibia non union and removed the 2.4mm cortex screw.This report is for one (1) 2.4 cortex screw slf-tpng t8 sd rec 20.This is report 1 of 6 for complaint (b)(4).

• Brand Name: 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 20
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): GRENCHEN SYNTHES PRODUKTIONS GMBH; solothurnerstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer (Section G): DEPUY MOTION SARL; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12789116
• Report Number: 3009450884-2021-00008
• Device Sequence Number: 11959190
• Product Code: HRS
• UDI-Device Identifier: 10886982142788
• UDI-Public: (01)10886982142788
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K002271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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
• Device Model Number: 201.770
• Device Catalogue Number: 201.770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNK - PLATES: LCP DISTAL TIBIA T-PLATE; UNK - PLATES: TUBULAR; UNK - SCREWS: 2.7 MM LOCKING; UNK - SCREWS: 3.5 MM LOCKING; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 104 KG