MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/LEFT

Catalog Number	03.111.601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: 510k: this report is for an unk - guides/ sleeves/aiming/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 or Problem 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 fracture of distal radius.In the surgery, the screw of the guiding block broke.The broken part of the screw stuck to the hole of the plate and could not be removed.The surgeon gave up using the plate and used another new plate.The surgery was completed with no surgical delay.No further information is available.This complaint involves two(2) devices.This report is for (1) unk - guides/ sleeves/aiming.This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).510k: this report is for an unk - guides/ sleeves/aiming/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 or Problem 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 fracture of distal radius.In the surgery, the screw of the guiding block broke.The broken part of the screw stuck to the hole of the plate and could not be removed.The surgeon gave up using the plate and used another new plate.The surgery was completed with no surgical delay.No further information is available.This complaint involves two(2) devices.This report is for (1) unk - guides/ sleeves/aiming.This report is 2 of 2 for (b)(4).
Event or Problem Description
This report is for one (1) guide block for 2 column plate 6 hole head/left.
Additional 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.H3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the guidingblock f/2-column dist-rad-pl2.4 6 (product code: 03.111.601 lot number: 10-3114) is broken from the fixing screw.A dimensional inspection was not performed for the guidingblock f/2-column dist-rad-pl2.4 6 (product code: 03.111.601 lot number: 10-3114) due to post manufacturing damage.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for guidingblock f/2-column dist-rad-pl2.4 6 (product code: 03.111.601 lot number: 10-3114).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.H3, h4, h6: a device history record (dhr) review was conducted: part # 03.111.601, lot # 10-3114, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date: 08 jul 2010.A manufacturing record evaluation was performed for the finished device lot number, 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: GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/LEFT
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13155483
• Report Number: 8030965-2022-00044
• Device Sequence Number: 17495693
• Product Code: FZX
• UDI-Device Identifier: 07611819352537
• UDI-Public: (01)07611819352537
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.111.601
• Device Lot Number: 10-3114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA
• Patient Sex: Unknown