MAUDE Adverse Event Report: SYNTHES GMBH TABLE TOP ROD CUTTER AND BENDER; CUTTER, SURGICAL

Catalog Number 388.750

Device Problem Material Integrity Problem (2978)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the table top rod cutter and bender broke.There was no patient or surgical impact.There is no further information available.This report is for one (1) table top rod cutter and bender.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: part 388.750; lot: 79p9335; manufacturing date: december 01, 2020.A device history record (dhr) review was performed for the finished device lot number and the production was according to the requirements and no non-conformance was identified within dhr.The inspection sheet showed the evidence for the functional control of cutting and bending and all parts of the lot have passed the tests.Visual inspection: the uss rod cut+bend-device was returned and received at us customer quality (cq).Upon visual inspection, no issues were identified with the returned device.Reported condition of broken could not be confirmed.Functional test: a functional test was performed on the returned device.The device was able to be opened and closed with large amount of resistance.The device was not able to opened completely.The device was not functioning as intended.Dimensional inspection: complaint relevant dimensional analysis could not be performed due to the geometry of the device.Document/specification review: the drawing(s) (current and manufactured to) were reviewed.No design issues or discrepancies were found during this investigation.Investigation conclusion: the complaint could be confirmed for the returned device.A definitive root cause could not be identified for the reported issue from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.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: TABLE TOP ROD CUTTER AND BENDER
• Type of Device: CUTTER, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SYNTHES UMKIRCH (DE); im kirchenhürstle 4-6; umkirch bei freiburg 79224 ; GM 79224
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13063325
• MDR Text Key: 288662339
• Report Number: 8030965-2021-10408
• Device Sequence Number: 1
• Product Code: FZT
• UDI-Device Identifier: 07611819053243
• UDI-Public: (01)07611819053243
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.750
• Device Lot Number: 79P9335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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