MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM TI VA-LCP LAT DSTL HUM PL 1H/RT/69MM SHRT-STER; PLATE, FIXATION, BONE

Catalog Number	04.117.801S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional 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.: b3: unknown when secondary fracture occurred.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter is j&j company representative.H3, h4, h6: 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
Device report from synthes reports an event in japan as follows: the patient underwent orif surgery for humeral diaphyseal fracture about 7 years ago and a plate implanted.The humerus was re-fractured at the proximal end of that plate, so the outer plate was scheduled to be replaced.This pc is related to (b)(4) which reports the plate removal difficulty in the replacement surgery.This pc reports the re-fracture 7 years after the primary surgery.This report is for va-lcp dhp 2.7/3.5 lat r short 1-ho l69 for (b)(4).

• Brand Name: 2.7MM/3.5MM TI VA-LCP LAT DSTL HUM PL 1H/RT/69MM SHRT-STER
• Common Device Name: PLATE, 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: 18395091
• Report Number: 8030965-2023-16153
• Device Sequence Number: 16808973
• Product Code: HRS
• UDI-Device Identifier: 10886982106971
• UDI-Public: (01)10886982106971
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Catalogue Number: 04.117.801S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/26/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown