MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS; GAUGE,DEPTH

Model Number 03.010.072

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: investigation flow: damage.Visual inspection: the depth gauge for locking screws to 100mm for im nails (p/n: 03.010.072, lot number: 8556353) was received at us cq.Visual inspection of the complaint device showed the tip of the needle/hook component was bent.Device failure/defect identified? yes.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as the device needle/hook component is bent but not broken.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.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: 03.010.072, lot: 8556353, manufacturing site: (b)(4), release to warehouse date: feb.25, 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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 on (b)(6) 2020, one (1) stepped drill bit cannulated did not function; six (6) depth gauge for locking screws, two (2) locking bolt measuring device, and one (1) titanium sternal locking straight plate were found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement this report is for (1) depth gauge for locking screws to 100mm for im nails.This is report 04 of 10 of (b)(4).

• Brand Name: DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS
• 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): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9647719
• MDR Text Key: 197316958
• Report Number: 2939274-2020-00541
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982067449
• UDI-Public: (01)10886982067449
• 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: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.072
• Device Catalogue Number: 03.010.072
• Device Lot Number: 8556353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2014
• 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