MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM DEPTH GAUGE 0 TO 60MM; GAUGE, DEPTH

Model Number 03.133.080

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Occupation: initial reporter is synthes sales representative the 2.7/3.5 mm depth gauge 0 to 60 mm (part #: 03.133.080, lot #: mgnq090) was received at us cq.Upon visual inspection, it was observed that the needle component of the complaint device was bent at the proximal end, where it connects to the center shaft, and in the center of the needle component.No other issues were identified on the device.The complaint condition was confirmed as the needle component of the complaint device was bent at the proximal end, where it connects to the center shaft, and in the center of the needle component.While no definitive root cause could be determined, it is possible the device encountered unintended forces during use.No definitive root cause could be determined based on the provided 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 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 history lot, part # 03.133.080, synthes lot # mgnq090, supplier lot # mgnq090, release to warehouse date: 31 may 2019, supplier: mack holding company, 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.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 on (b)(6) 2020, the sterile processing department (spd) found several broken items that were used and discovered post-operatively.One (1) spare reamer tube for hollow reamer was grinded and broken.One 2.7/3.5 mm depth gauge and one (1) screwdriver for 4.5 mm titanium multiloc screws were damaged.No procedural or patient information available.This report is for (1) 2.7/3.5 mm depth gauge 0 to 60 mm.This is report 3 of 3 for (b)(4).

• Brand Name: 2.7/3.5MM DEPTH GAUGE 0 TO 60MM
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10547121
• MDR Text Key: 208011674
• Report Number: 2939274-2020-04175
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982269690
• UDI-Public: (01)10886982269690
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.133.080
• Device Catalogue Number: 03.133.080
• Device Lot Number: MGNQ090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2019
• 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