MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LCP PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Catalog Number 441.903S

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A device history record (dhr) review was conducted: part #: 441.903s, lot #: l242708, manufacturing site: werk raron, supplier: n/a.Release to warehouse date: 20 jan 2017, expiration date: 01 jan 2027.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent surgery for fracture of proximal end of humerus with the plate.In postoperative rehabilitation, the surgeon instructed the patient to perform a pendulum exercise.Two (2) weeks after the surgery, internal inversion was observed in the follow-up.The future plan will be determined after consultation with the surgeon at the other hospital.No further information is available.This report is for one (1) 3.5mm ti lcp proximal humerus plate-standard 5h shaft/114mm this is report 1 of 2 for complaint (b)(4).

• Brand Name: 3.5MM TI LCP PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13637002
• MDR Text Key: 288653599
• Report Number: 8030965-2022-01239
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 07611819797796
• UDI-Public: (01)07611819797796
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K011815
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 441.903S
• Device Lot Number: L242708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention