MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS; GAUGE, DEPTH

Model Number 03.111.005

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021, during an open reduction and internal fixation (orif) of the distal radius, the depth gauge was used in surgery and was not sliding smoothly.After the case it was discovered that the metal inside the depth gauge is not sliding up the slide mechanism.It is unknown if there was a surgical delay.The procedure was completed successfully.This report involves one (1) depth gauge for 2.0mm/2.4mm and 2.7mm screws.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Product complaint # (b)(4).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.Visual inspection: the depth gauge for 2.0mm/2.4mm and 2.7mm screws (p/n: 03.111.005, lot number: 8608216) was received at juarez pal.Upon visual inspection, it was noticed that the needle component is bent.The sliding mechanism is difficult to use.The rest of the device shows surface wear consistent with use and which would not impact the functionality.As the reported event is jammed/seized the complaint cannot be confirmed, however the deformed/ bent of the needle event will be added.Device failure/defect is identified and the complaint is confirmed.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Investigation conclusion: the reported condition is not confirmed, however the needle component is bent.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: 03.111.005, lot: 8608216, manufacturing site: hagendorf, supplier: n/a, release to warehouse date: 05 december 2013, expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances 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.

• Brand Name: DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS
• 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): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12804878
• MDR Text Key: 282520631
• Report Number: 2939274-2021-06667
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982072078
• UDI-Public: (01)10886982072078
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.111.005
• Device Catalogue Number: 03.111.005
• Device Lot Number: 8608216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2013
• 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
• Patient Age: 42 YR
• Patient Sex: Male