MAUDE Adverse Event Report: SYNTHES GMBH ROD CUTTER; CUTTER, WIRE

Catalog Number 388.720

Device Problem Break (1069)

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

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(6) reports an event as follows: it was reported that during a surgery on (b)(6) 2021, the blade of the rod cutter broke off while cutting a rod.No fragments had any impact with the patient.Surgery successfully completed with another available rod cutter.There was no surgery delay.Patient outcome was good and as intended.This report is for a rod cutter.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual inspection: the boltcutter (part #: 388.720, lot #: t197216) was received at us cq.Upon visual inspection, one of the distal cutting jaws have a portion of the cutting surface broken off and the broken piece was not returned.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: the complaint-relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed for the received device.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces during its use.No new malfunctions were observed during this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot lot t1972216 is unknown in tuttlingen.However, for article 388.720, a lot with the number t197216 was produced, so the dhr review is carried out for this lot.Part number: 388.720, lot number: t197216, manufacturing site: tuttlingen, release to warehouse date: 23-jul-2020 ((b)(4) devices), 27-aug-2020 ((b)(4) devices).A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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: ROD CUTTER
• Type of Device: CUTTER, WIRE
• 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: 12482444
• MDR Text Key: 271745331
• Report Number: 8030965-2021-07807
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819710504
• UDI-Public: (01)07611819710504
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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,Followup,Followup
• Report Date: 09/06/2021

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: 388.720
• Device Lot Number: T197216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 11/19/2021; 03/22/2022
• Supplement Dates FDA Received: 12/03/2021; 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1