MAUDE Adverse Event Report: SYNTHES GMBH 13.0MM CANNULATED DRILL BIT 300MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Catalog Number 351.270

Device Problem Break (1069)

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

Event Date 01/16/2022

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: gff, gfa, hwe.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 depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022 during a knee surgery, the 13mm opening reamer from the retrograde femoral nail set broke.The broken part was easily removed with the power tool.The surgeon used the longer 13mm from the same set to finish the case.The surgery was delayed for two (2) minutes due to the reported event.The procedure was successfully completed.Patient outcome was not compromised.This report is for one (1) 13.0mm cannulated drill bit 300mm.This is report 1 of 1 for complaint (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.H3, h6: product code #: 351.270, synthes lot #: f-11989, manufacturing site: werk selzach logistik, release to warehouse date: september 23, 2011, supplier: (b)(4).A manufacturing record evaluation was performed for the non-sterile article lot and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that 13.0mm cannulated drill bit 300mm has a broken condition at the proximal section, no other damages or anomalies were observed on the device.A dimensional inspection was not performed for the 13.0mm cannulated drill bit 300mm since during the visual inspection it was noted that the device is broken at the proximal section, however, the broken condition is a post-manufacturing damaged, and it is not related with the manufacturing of the device.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces, however this cannot be conclusively determined.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the broken condition observed on the 13.0mm cannulated drill bit 300mm would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: 13.0MM CANNULATED DRILL BIT 300MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13524922
• MDR Text Key: 290546444
• Report Number: 8030965-2022-00872
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 07611819048324
• UDI-Public: (01)07611819048324
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 351.270
• Device Lot Number: F-11989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2011
• 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