MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM CANNULATED DRILL BIT/QC 150MM; INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number 310.221

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/06/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: hwc gfa gff.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for nonunion after carpal bone fracture.During the surgery, when the surgeon inserts the drill bit a few millimeters, the drill bit was broken in both bone and drill sleeve.The instrument was divided into three parts and broken like popping.The surgery was completed successfully within 30 minutes delay.The patient condition was stable.Concomitant device reported: unk - guides/sleeves/aiming: sleeve (part# unknown; lot# unknown; quantity: 1).Unk - screws: cannulated headless (part# unknown; lot# unknown; quantity: 1).This complaint involves one(1) device.This report is for (1) 2.0mm cannulated drill bit/qc 150mm.This report is 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.Part # 310.221 synthes lot # pe04618 supplier lot # pe04618 release to warehouse date: december 24, 2020 supplier: (b)(4) no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that drill bit ø2/1.15 cann l150/48 3flute the drill bit was broken, and broken piece was also returned no other issues were identified however the embedded condition cannot be confirmed since no xray¿s were provided.The dimensional inspection was not performed due to post manufacturing damage.The observed condition drill bit ø2/1.15 cann l150/48 3flute in the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed broken condition of the drill bit ø2/1.15 cann l150/48 3flute.While no definitive root cause could be determined, it is probable that the drill bit ø2/1.15 cann l150/48 3flute was broken due to the unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.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.Drawing/specifications reviewed? the following drawing reflecting the current and manufacture revision was reviewed: - 2.0 cannulated drill with quick coupling 150 mm 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: 2.0MM CANNULATED DRILL BIT/QC 150MM
• Type of Device: INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12482614
• MDR Text Key: 271750208
• Report Number: 8030965-2021-07808
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 07611819086074
• UDI-Public: (01)07611819086074
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.221
• Device Lot Number: PE04618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2020
• 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
• Treatment: UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - SCREWS: CANNULATED HEADLESS; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - SCREWS: CANNULATED HEADLESS
• Patient Outcome(s): Required Intervention