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

Catalog Number 04.117.401S

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part #: 04.117.401s, lot #: 73p1473, manufacturing site: (b)(4), release to warehouse date:04 nov 2020, expiry date: 01.Oct.2030.A manufacturing record evaluation was performed for the sterile lot number, and no non-conformance's 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the osteosynthesis surgery for the distal humerus with the plate.During the plate bending, the plate cracked.The surgeon used another plate and the surgery was completed successfully within thirty (30) minutes delay.Patient outcome is reported as stable.No further information is available.This report is for one (1) 2.7/3.5mm ti va-lcp medl dstl hum pl/1h/rt/69mm-short-ster.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7/3.5MM TI VA-LCP MEDL DSTL HUM PL/1H/RT/69MM-SHORT-STER
• Type of Device: PLATE, 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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11204383
• MDR Text Key: 227974862
• Report Number: 8030965-2021-00464
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 7611819504912
• UDI-Public: (01)7611819504912
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.117.401S
• Device Lot Number: 73P1473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1