MAUDE Adverse Event Report: SYNTHES GMBH HOLDING FORCEPS

Catalog Number	351.782
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes (b)(6) reports an event as follows: it was reported the device was not working properly.There was reported no consequence to the patient.Upon visual inspection of the returned device, it was seen that one of the jaws of the holding forceps was broken.This report is for holding forceps.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Part 351.782, lot t187329: manufacturing site: (b)(4).Release to warehouse date: april 01, 2020.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.A product investigation was completed: upon visual inspection, it is seen that one of the jaws of the holding forceps was broken.The device shows normal wear consistent with use.A functional assessment could not be performed as the complaint device was broken, but the broken condition could have caused the functionality issue.The following current and manufactured to drawings were reviewed.The complaint condition was confirmed for the holding forceps as it was broken.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.

• Brand Name: HOLDING FORCEPS
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13087316
• Report Number: 8030965-2021-10465
• Device Sequence Number: 20261451
• Product Code: HTD
• UDI-Device Identifier: 07611819259775
• UDI-Public: (01)07611819259775
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: Health Professional
• Device Catalogue Number: 351.782
• Device Lot Number: T187329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown