MAUDE Adverse Event Report: SYNTHES GMBH CONNECSCR F/DHS/DCS-WRENCH NO. 338.300; EXTRACTOR

Catalog Number 338.31

Device Problem Material Integrity Problem (2978)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

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.Investigation summary - picture review: on the received picture there is a connecting screw, f/dhs/dcs® wrench visible with a unknown damage.Unfortunately, the poor quality of the picture does not allow to a clear definition of the damage.The complaint is rated as confirmed as the connecting screw, f/dhs/dcs® wrench is damaged.Product was not returned; therefore, no further investigation is possible.The review of the picture does not allow to any determination of any root cause.Investigation conclusion - while a definitive root cause cannot be determined, it is possible that the device might have encountered unintended forces.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, 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.Therefore, it has been determined that no corrective and/or preventive action is proposed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that, instrument was delivered damaged to the hospital.Procedure couldn't be executed as smoothly as normal, but no actual indication of how long of a delay was and as a result the instrument was damaged.As this instrument was part of a loan set, third party supplier of loan sets had been informed about this issue.This report is for one (1) dhs®/dcs® coupling screw.This is report 1 of 1 for complaint (b)(4).

• Brand Name: CONNECSCR F/DHS/DCS-WRENCH NO. 338.300
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11777828
• MDR Text Key: 280506962
• Report Number: 8030965-2021-03583
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819022133
• UDI-Public: (01)07611819022133
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 04/08/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 338.31
• Device Lot Number: 2L04656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DHS/DCS-SCR Ø12.5 L95 SST