MAUDE Adverse Event Report: SYNTHES BRANDYWINE DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS GAUGE, DEPTH

Catalog Number 319.004

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted. 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

It was reported that the tip of a depth gauge has broken off. This was found already broken during right hand open reduction internal fixation (orif) on (b)(6) 2017. It appeared that a portion of the tip was missing -no hook exists any longer. There was a five (5) minute surgical delay related to obtaining a back-up instrument. Intra-operative x-ray confirmed no fragments in the patient. The procedure was completed successfully with the patient in stable condition. This report is for one (1) depth gauge. This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Dhr review for part # 319. 004 lot # 5751134. (b)(4) was issued for potential undersizing of subcomponents. A product hold was issued in 2013 for (b)(4) pieces. Subcomponent 319. 004. 03, lot#5593110 (b)(4) was generated for l5 oversize and l7 undersize needle dimensions. (b)(4) pieces were returned for rework. (b)(4) was generated for nonconformance l5 oversize and l7 undersize needle dimensions. (b)(4) pieces were accepted and (b)(4) pieces were scrapped. Relevance to the complaint condition cannot be determined until the product is returned for investigation. Review of device history records showed that there are potential issues during the manufacture of this product that would contribute to this complaint condition. Release to warehouse date: 11-apr-2008 manufactured by: synthes (b)(4). One depth gauge for 1. 3mm and 1. 5mm screws (part# 319. 004/lot# 5751134) was received at customer quality (cq) for evaluation with complaint category broken: tip broken intraoperatively. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition. A visual inspection, device history review, and drawing review were performed as part of this investigation. This complaint is confirmed. The device is a part of the rotation correction plates ¿ 2. 0mm lcp and 1. 5mm/2. 0mm and is used to determine the screw length for 1. 3 mm and 1. 5 mm screws a visual inspection under 5x magnification, device history record (dhr) review, and drawing review were performed as part of this investigation. No product design issues or discrepancies were observed. All parts of the device were returned intact. The distal tip of the needle no longer contains the hook and has a rough texture. Using ca592, the needle was measured to be 49. 20mm in length, and device drawing specifies the range 55. 40 - 53. 80 mm. The width of distal tip of the device was measured to be 0. 70 mm, and device drawing specifies the range 0. 63 - 0. 7 mm. The overall condition of the device is good, with minimal wear over the device¿s 9-year lifetime. Replication of the complaint condition is not applicable as the instrument was returned in broken condition. Dhr review: although the mrrs are related to the undersizing of the needle dimensions, the depth gauge was in use for nine years prior to material failure, making the product¿s lifetime the most likely root cause. Generally, incorrect dimensioning would have contributed to an earlier material fatigue. Drawings for the device were reviewed. No drawing issues or discrepancies were noted. The design is adequate for its intended use and did not contribute to this complaint condition. This complaint is confirmed; the returned device was received at cq with damage to the distal end of the needle. The returned device is multiple use and needed during various procedures; therefore, the complaint condition was most likely caused by repetitive use over the product¿s lifetime. However, based upon the given information, a definitive root cause is indeterminable. It is not likely that the design of the instrument contributed to this complaint. No new, unique or different patient harms were identified as a result of this evaluation. 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: DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6534761
• MDR Text Key: 74162739
• Report Number: 2530088-2017-10104
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 319.004
• Device Lot Number: 5751134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown