MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS 240MM SPEED LOCK AWSL

Catalog Number 399.05

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 01/25/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.(b)(4).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, during a mid shaft femur procedure, the surgeon attempted to use a reduction forceps to grab a femur.The arm broke while tightening.Fragments were generated but removed easily.There was a surgical delay of one (1) minute.The procedure was successfully completed.Patient status was stable.This is report 01 of 01 of (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4: udi number: gtin unavailable, product made prior to gtin compliance date.H6: the following investigation is based on the image provided.The image was reviewed, and the complaint condition could be confirmed.After reviewing the image of the reduction forceps, it was seen that the arm of forceps handle 2 was broken.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.H11 corrected data: 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

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.H10 additional narrative: h3, h6: investigation summary.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image provided in the attachment "(b)(4) intake email received from sales consultant on (b)(6) 2020".The image was reviewed, and the complaint condition could be confirmed.After reviewing the image of the reduction forceps, it was seen that the arm of forceps handle 2 was broken.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Investigation flow: damage.Visual inspection: the reduction forceps 240mm speed lock awsl (part # 399.05/ lot # 897) was received at us cq.One of the forcep jaws was broken proximal to its first serrated tooth.The screw in the center of the device to lock the forceps position was mildly bent.The received condition was consistent with the complaint condition thus the complaint was confirmed.Device failure/defect identified? yes; one of the forcep jaws was broken.Dimensional inspection: dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: drawing(s) reviewed: an mre was not performed so the current revision of the drawing was reviewed.Conclusion: the overall complaint was confirmed for the received reduction forceps 240mm speed lock awsl as one of the forcep jaws was broken proximal to its first serrated tooth.Although no definitive root-cause can be determined its possible the device experienced unintended forces.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 number: 399.05.Lot number: 897.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure 100673626 no manufacturing record evaluation is required.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: REDUCTION FORCEPS 240MM SPEED LOCK AWSL
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9717152
• MDR Text Key: 193651742
• Report Number: 2939274-2020-00873
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2020

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 Catalogue Number: 399.05
• Device Lot Number: 897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Manufacturer Received: 01/25/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 02/18/2020; 03/06/2020
• Supplement Dates FDA Received: 02/19/2020; 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR