MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SLIDE/FIXED HAMMER 400 GRAMS; HAMMER, SURGICAL

Catalog Number	03.010.058
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records has been requested.The device has been received, the investigation is in progress, 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
It was reported that during an unknown case on (b)(6) 2018, a reamer / irrigator / aspirator (ria) system was used to harvest bone graft from a patient.Bone graft was performed to replace a pacer where a bone void was.The humeral nail- expert instrument and implant set were opened to use a drill bit from the set to open the femoral canal to use the ria system.Upon inspection of the opened set, it was noticed that the handle of the mallet was broken.The mallet was not used or needed during the case.The humeral nail- ex set was opened for the 10.0mm cannulated drill bit.The case went well and as planned.There was no surgical delay.Procedure and patient outcome were successfully completed.This report is for one (1) slide/fixed hammer 400 grams.This is report 1 of 1 for complaint (b)(4).
Event or Problem Description
It was reported that during an unknown case on (b)(6) 2018, a reamer/irrigator/aspirator (ria) system was used to harvest bone graft from a patient.Prior to bone grafting, a 4.5mm locking compression plate (lcp) condylar plate was implanted.There was no malfunction of the lcp condylar plate.Patient had a huge bone void.The spacer that was implanted initially was replaced with bone graft harvested from ria.The humeral nail- expert instrument and implant set was opened to retrieve a drill bit from the set.Upon inspection of the opened set, it was noticed that the handle of the mallet was broken.The mallet was not used or needed during the case.The case went well and as planned.It is unknown if there was a surgical delay.Procedure outcome was unknown.
Additional Manufacturer Narrative
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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device history: part number: 03.010.058.Synthes lot number: 4982345.Release to warehouse date: 28-oct-2005.Manufacturing site: synthes brandywine.No ncrs were generated during production.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Device history batch null, device history review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation summary: broken.Visual inspection: visual inspection of the returned device performed at customer quality (cq) confirmed the condition of handle breakage, which agrees with the reported complaint condition.A portion of the handle has broken off and was returned loose in the bag.The axial break occurred at the location of the dowel pin which secures the handle to the shaft.Does received condition agree with the complaint description? yes.Dhr review: the returned hammer was manufactured in october 2005 and is over 13 years old.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Document/specification review: the following design drawings were reviewed as part of investigation a reusable instrument in the dynamic helical hip system and humeral nail-ex system which is utilized with the titanium cannulated humeral nail system.The slide/fix hammer is specifically used to aid in antegrade and retrograde nail insertion, insertion of spiral blades and the removal of both the spiral blades and nails.No product design issues or discrepancies were observed during this investigation.Material analysis: the design specified the handle to be manufactured from phenolic le grade linen material.A review of the dhr showed that the handle raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Was the complaint confirmed? yes.Conclusion: a definitive root cause for the handle breaking on the returned 13 year old hammer could not be determined based on the provided information.It is possible that over 13 years of impact forces has contributed.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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.

• Brand Name: SLIDE/FIXED HAMMER 400 GRAMS
• Common Device Name: HAMMER, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8122569
• Report Number: 2939274-2018-55231
• Device Sequence Number: 1569996
• Product Code: FZY
• UDI-Device Identifier: 10886982067296
• UDI-Public: (01)10886982067296
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2018

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: 03.010.058
• Device Lot Number: 4982345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 12/28/2018; 01/08/2019
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 12/28/2018; 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1