MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM TI VA-LCP LAT ANT CLAVICLE PL/10H/101MM-STER; SCREW, FIXATION, BONE

Model Number	04.112.047S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter facility name: (b)(6).Manufacturing location: (b)(4) / packaged, sterilized and released by: monument.Release to warehouse date: 07-oct-2019.Expiration date: 01-sep-2029.Part number: 04.112.047s, 2.7mm/3.5mm ti va-lcp lat ant clavicle pl/10h/101mm-sterile.Lot number: 17p9263 (sterile).Note: plate was manufactured by (b)(4); lot number 15l6865.Parts were thermal rinsed, packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) lmd was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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 (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for fracture of shaft of clavicle with the plate.After reduction, the plate was placed, but the surgeon said that the plate did not fit well along the bone.The surgeon tried to bend the plate to be fit along the bone, but he gave up bending because a bender was not arranged.The surgery was completed without any surgical delay.In the postoperative photographs, the reduction position was not good, and it seemed that the plate did not fit along the bone well.This report involves one (1) 2.7mm/3.5mm ti va-lcp lat ant clavicle pl/10h/101mm-ster.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM/3.5MM TI VA-LCP LAT ANT CLAVICLE PL/10H/101MM-STER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12252578
• Report Number: 8030965-2021-06259
• Device Sequence Number: 17064301
• Product Code: HWC
• UDI-Device Identifier: 10886982102812
• UDI-Public: 10886982102812
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 04.112.047S
• Device Catalogue Number: 04.112.047S
• Device Lot Number: 17P9263
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/30/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - BENDING INSTRUMENTS: PLATE BENDER: TRAUMA