MAUDE Adverse Event Report: SYNTHES GMBH BOLT CUTTER HANDLE 13MM WIDTH ACROSS FLATS; INSTRUMENT, CUTTING, ORTHOPAEDIC

Catalog Number 391.780

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj representative.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the handle of bolt cutting head has snapped in half.It was unknown if there any procedure involved.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) bolt cutter handle 13mm width across flats this report is 1 of 1 for (b)(4).

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.Investigation summary: the complaint condition, that the handle is broken in to two pieces, could be confirmed according to the received pictures.H3, h4, h6: device history lot part no.: 391.780, lot no.: 2016, manufacturing location: bettlach.Due to the age of more than 15 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction.Per franchise complaint product investigation procedure (b)(4) is for complaints for which a non-manufacturing related probable cause has been identified no manufacturing record evaluation is required.Furthermore, at this time the manufacturing documents for instruments had to be stored for 10 years.This was according to se_075477 (filing and archiving of specification documents) version ai, which was in place till august 2014.Product was not returned.Based on the information available, it has been determined that no corrective and 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

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: investigation summary.Visual inspection: the handle ø13 f/bolt cutting head l455 (part #: 391.780 and lot #: 2016) was received at us cq.Upon visual inspection, the handle of the bolt cutter was broken.The broken part was returned at cq.There were also scratches on the device but have no impact on the device functionality.No other issues were identified with the returned device.Device failure/ defect found? yes.Dimensional inspection: a dimensional inspection was not performed due to the definitive finding of the broken handle of the device.Documentation/ specification review: since the age of the device is more than 15 years, the current drawing was reviewed.- handle d13.00 for bolt cutting head complaint confirmed? yes.Investigation conclusion: the complaint condition is confirmed as the handle of the device was broken.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces during its use.No new malfunctions were observed during this investigation.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.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: BOLT CUTTER HANDLE 13MM WIDTH ACROSS FLATS
• Type of Device: INSTRUMENT, CUTTING, ORTHOPAEDIC
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11388800
• MDR Text Key: 242714555
• Report Number: 8030965-2021-01437
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 07611819024700
• UDI-Public: (01)07611819024700
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2021

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 Catalogue Number: 391.780
• Device Lot Number: 2016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 03/10/2021; 03/29/2021
• Supplement Dates FDA Received: 03/26/2021; 04/21/2021
• Patient Sequence Number: 1